Clinical Research Operations Specialist

Numinus Wellness (TSX: NUMI) helps people to heal and be well through the development and delivery of innovative mental health care.

Our clinical research teams are top notch and participate in managing cutting edge clinical trials in the field of mental health.  If you are committed to excellence and in the belief of the power of one person making a difference in this world, come join us at Numinus.

This is a full-time onsite position at our Draper Utah location

Responsibilities:

• Performs clinical study activities in compliance with (ICH-GCP), Sponsor Standard Operating Procedures (SOPs) 

• May assist with Study Start-Up and Regulatory for site readiness. 

•  Work closely with other supporting clinical operations team members, if applicable, to execute clinical studies 

• Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents. 

• Participates in preparation for site selection and validation activities. 

• With assigned team, conducts site visits including but not limited to initiation visits, monitoring visits,  

• Assists with the collection of regulatory documentation for study start-up, study maintenance and study close-out with team. 

• Assist with maintaining information and documentation in Clinical Trial Master File (TMF) and various other systems as appropriate. Assists with audit/inspection activities as needed. 

• Review clinical monitoring reports to ensure timely completion and identification of issues with QA/QC Specialist/Training Mgr. and study team staff and Senior Leadership team. 

• Assists in the management of  study-status, cost and issues to ensure timely decision-making by senior management 

• Assist the assigned team with invoice and budget tracking for individual studies and provide input into budget forecasting activities 

Preferred Experience 

• Demonstrated project management skills 

• Clinical trial auditing and on site/remote monitoring 

• Good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies 

• Excellent verbal and written communication skills 

• Good organizational skills and attention to detail  

Preferred CCRC or CCRP certification 

• 5-7 years of experience in a clinical research setting with involvement in all phases of clinical trials